Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
- Conditions
- UC (Urothelial Cancer)
- Interventions
- Registration Number
- NCT03374488
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type.
- Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy.
- Measurable disease based on RECIST v1.1.
- Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function per protocol-defined criteria.
- Urothelial carcinoma that is suitable for local therapy with curative intent.
- History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
- Known history of or is positive for active hepatitis B (HBsAg reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
- Use of protocol-defined prior/concomitant therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab 200 mg + Epacadostat 100 mg BID Epacadostat Pembrolizumab + epacadostat Pembrolizumab 200 mg + placebo BID Placebo Pembrolizumab + placebo Pembrolizumab 200 mg + placebo BID Pembrolizumab Pembrolizumab + placebo Pembrolizumab 200 mg + Epacadostat 100 mg BID Pembrolizumab Pembrolizumab + epacadostat
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo up to 9 weeks +14 days ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
- Secondary Outcome Measures
Name Time Method Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE Up to 8 months AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs) Up to 8 months AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Trial Locations
- Locations (135)
Centre de Lutte Contre le Cancer Francois Baclesse
🇫🇷Caen, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Centre Leon Berard
🇫🇷Lyon, France
Macquarie University Hospital
🇦🇺Macquarie Park, Australia
University of California Irvine Medical Center
🇺🇸Orange, California, United States
UCLA Hematology Oncology Santa Monica
🇺🇸Santa Monica, California, United States
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
🇨🇦Quebec, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Northside Hospital, Inc. - GCS/Annex
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Southern Medical Day Care Centre
🇦🇺Wollongong, New South Wales, Australia
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Institut de Cancerologie de l Ouest Site Paul Papin
🇫🇷Angers, France
Centre Oscar Lambret
🇫🇷Lille, France
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitaetsklinikum Jena
🇩🇪Jena, Germany
Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
University of Chicago
🇺🇸Chicago, Illinois, United States
Adelaide Cancer Centre
🇦🇺Kurralta Park, Australia
Oklahoma Cancer Specialists & Research Institute
🇺🇸Tulsa, Oklahoma, United States
Clinique Sainte Catherine
🇫🇷Avignon, France
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hopital Cochin
🇫🇷Paris, France
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Vall D Hebron
🇪🇸Barcelona, Spain
Somogy Megyei Kaposi Mor Oktato Korhaz
🇭🇺Kaposvár, Hungary
Hospital del Mar
🇪🇸Barcelona, Spain
Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
🇩🇪Luebeck, Schleswig Holstein, Germany
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Samsun Medical Park Hastanesi
🇹🇷Samsun, Turkey
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Sunnybrook Research Institute
🇨🇦Toronto, Ontario, Canada
Adana Sehir Hastanesi
🇹🇷Adana, Turkey
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Tennessee Medical Center Knoxville
🇺🇸Knoxville, Tennessee, United States
US Oncology and Research
🇺🇸Fort Worth, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
VCU Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Hopital Saint Louis
🇫🇷Paris, France
Centre Medico-Chirurgical Foch
🇫🇷Suresnes, France
Universitaetsklinikum Magdeburg A.o.R.
🇩🇪Magdeburg, Germany
Beaumont Hospital
🇮🇪Dublin, Ireland
University College Hospital Galway
🇮🇪Galway, Ireland
University Hospital Limerick
🇮🇪Limerick, Ireland
Waterford Regional Hospital
🇮🇪Waterford, Ireland
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Medical Oncology Ospedale San Donato
🇮🇹Arezzo, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark
Sjaellands Universitetshospital Naestved
🇩🇰Næstved, Denmark
Medical University of South Carolina-Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Austin Health-Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
🇭🇺Miskolc, Hungary
Pecsi Tudomanyegyetem AOK
🇭🇺Pécs, Hungary
Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet
🇭🇺Szolnok, Hungary
Rabin Medical Center
🇮🇱Petach-Tikwa, Israel
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Nara, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
VU University Medical Center
🇳🇱Amsterdam, Netherlands
Dokuz Eylul University Faculty of Medicine
🇹🇷İzmir, Turkey
National Medical Research Radiological Centre
🇷🇺Moscow, Russian Federation
CIUSSS - Hopital Maisonneuve- Rosemont
🇨🇦Montréal, Quebec, Canada
Cork University Hospital
🇮🇪Cork, Ireland
Soroka Medical Center
🇮🇱Be'er Sheva, Israel
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Meir Medical Center
🇮🇱Kfar Saba, Israel
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Medical Hospital, Tokyo Medical And Dental University
🇯🇵Tokyo, Japan
Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
Adelaide & Meath Hospital (Incl NCH)
🇮🇪Dublin, Ireland
Rambam Medical Center
🇮🇱Haifa, Israel
Chang Gung Medical Foundation. Kaohsiung Branch
🇨🇳Kaohsiung, Taiwan
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH
🇹🇷Ankara, Turkey
Antoni van Leeuwenhoek Ziekenhuis
🇳🇱Amsterdam, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
N.N. Blokhin NMRCO
🇷🇺Moscow, Russian Federation
Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)
🇯🇵Tokyo, Japan
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Leningrad Regional Oncology Dispensary
🇷🇺Saint Petersburg, Leningrad Region, Vsevolozhsky District, Russian Federation
Ivanovo Regional Oncology Dispensary
🇷🇺Ivanovo, Russian Federation
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Pokrovskaya City Hospital
🇷🇺Saint Petersburg, Russian Federation
Royal Marsden NHS Trust
🇬🇧Sutton, Surrey, United Kingdom
Russian Scientific Center of Roentgenoradiology
🇷🇺Moscow, Russian Federation
Ryazan Regional Clinical Oncology Dispensary
🇷🇺Ryazan', Russian Federation
Clinic of Bashkortostan State Medical University
🇷🇺Ufa, Russian Federation
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Akdeniz Universitesi Tip Fakultesi
🇹🇷Antalya, Turkey
Pamukkale Unv. Tip Fak.
🇹🇷Denizli, Turkey
Trakya Universitesi Tip Fakultesi
🇹🇷Edirne, Turkey
Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi
🇹🇷Istanbul, Turkey
Institut du Cancer de Montpellier
🇫🇷Montpellier, France
Institut Jean Godinot
🇫🇷Reims, France
C.H.U. de Tours - Hopital Bretonneau
🇫🇷Tours, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Plymouth Hospitals NHS Trust
🇬🇧Plymouth, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital
🇬🇧London, United Kingdom
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Klinikum rechts der Isar der Technischen Universitat
🇩🇪Muenchen, Germany
MD Anderson Cancer Center Madrid
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Instituto Valenciano de Oncologia
🇪🇸Valencia, Spain
NYU Clinical Cancer Center
🇺🇸New York, New York, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Smilow Cancer Center at Yale-New Haven
🇺🇸New Haven, Connecticut, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom